Continuing my series on recent off-label qui tam cases against pharma companies, last year AstraZeneca paid $520 million to resolve allegations that it illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).
Click here for the DoJ press release.
Click here for the settlement agreement.
Click here for the Corporate Integrity Agreement between AstraZeneca and HHS-OIG.